MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

Device Problem Unexpected Shutdown (4019)

Patient Problem Hypovolemia (2243)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the motor stopped "for a few seconds" with rpms and flows to zero three times.The motor restarted without any intervention at previous set of rpms.The patient was switched to back up equipment.There was no reported prior procedure or preceding event before the motor failure.The patient required an increase in inotropic support and was given volume due to the event.

Event Description

Related manufacturer reference number: 3003306248-2022-00058.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag 2nd generation primary console (serial #: (b)(6)) was returned for evaluation with the reported event of the motor speed and flow dropping was confirmed.The 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately ((b)(6) 2022 per time stamp).Events occurring on (b)(6) 2022 took place during lab testing at abbott.The console was operating a pump at the speed of 4500 rpm with a flow of 4.9lpm.On (b)(6) 2022 at 15:47:13, sub fault ¿sf_ifd_speed_mismatch¿ activated and the speed dropped to 0 rpm and the flow became a negative value.¿set pump speed not reached: m5¿ and ¿flow below minimum: f3¿ alarms were active.These alarms cleared and the speed and flow were resumed at 15:47:25.This sequence of events occurred again at 15:48:15.The speed and flow was maintained until the console was powered down on (b)(6) 2022 at 17:26:48.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned to the service depot.The console was connected to a test loop and was run for several days.No alarms were observed.A full functional test was performed, and all tests were passed.The reported event was unable to be correlated to an issue with the returned console.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual table 16 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including m5 and f3 alarms.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14046527
• MDR Text Key: 289973974
• Report Number: 3003306248-2022-00059
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: IFS102669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 108 KG